Effects of Bright-light Exposure Combined With Specific Exercise Training (BEST) Program in Patients With Cancer

NCT ID: NCT05875870

Last Updated: 2024-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-24

Study Completion Date

2028-05-15

Brief Summary

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This study plans to investigate the effectiveness of six-week light exposure combined with an exercise training program on improving sleep-wake rhythm, physical and mental symptoms, quality of life, one-year recurrence rate, and one-year survival rate of patients with lung and esophageal cancer.

Detailed Description

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This study plans to investigate the effectiveness of six-week light exposure combined with an exercise training program on improving sleep-wake rhythm, physical and mental symptoms, quality of life, one-year recurrence rate, and one-year survival rate of patients with lung and esophageal cancer.

Two groups, parallel, randomly assigned clinical trials, long-term follow-up, repeated measurement (pre-test, 6th week, 12th week, 6th month, 12th month, five times in total), and a design of single center recruitment. The experimental group receiving an intervention comprised six weeks of light exposure combined with exercise training. The active control group receiving six weeks of stretching exercise. With a double-blind study design of participant blind and outcomes assessor blind, subjects were recruited from the thoracic surgery clinic and thoracic surgery ward of a medical center in northern Taiwan.

Conditions

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Lung Neoplasm Esophageal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Experimental group

The rehabilitation program is composed of two parts: six-week bright-light exposure program and an exercise program.

Group Type EXPERIMENTAL

Daylight exposure combine walking

Intervention Type BEHAVIORAL

1. Out-door of bright-light exposure in the morning (36 min/day, 7 times/week) for six weeks.
2. Tailored to the individual patient with moderate intensity of walking (3 sessions/week) for six weeks. Duration of each session depends on one-on-one exercise consultation via communication software (LINE App). The duration of walking in week 1 is 15 minutes, then increasing 5 minutes each week if the patient has tolerance. If the patient cannot tolerate the duration, the coach will instruct to keep the same duration for the following week. Basically, the goal of duration in week six is 40 minutes.
3. Weekly exercise consultation via communication software (LINE App).
4. Teaching strategy includes one-on one instruction (hard-copy of teaching manual), video, and webpage.

Active control group

The active control group receives six weeks of a stretching exercise.

Group Type ACTIVE_COMPARATOR

Stretching exercise

Intervention Type BEHAVIORAL

The stretching exercise includes two movements for the upper body and two movements for the lower body, 10 minutes each time, three times a week, for 6 weeks.

The researcher will explain to the participants about how to perform the stretching exercise, according to an instruction manual (hardcopy) for the exercise regimen.

A video is shown to the participants (the content same as hardcopy of education manual).

Interventions

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Daylight exposure combine walking

1. Out-door of bright-light exposure in the morning (36 min/day, 7 times/week) for six weeks.
2. Tailored to the individual patient with moderate intensity of walking (3 sessions/week) for six weeks. Duration of each session depends on one-on-one exercise consultation via communication software (LINE App). The duration of walking in week 1 is 15 minutes, then increasing 5 minutes each week if the patient has tolerance. If the patient cannot tolerate the duration, the coach will instruct to keep the same duration for the following week. Basically, the goal of duration in week six is 40 minutes.
3. Weekly exercise consultation via communication software (LINE App).
4. Teaching strategy includes one-on one instruction (hard-copy of teaching manual), video, and webpage.

Intervention Type BEHAVIORAL

Stretching exercise

The stretching exercise includes two movements for the upper body and two movements for the lower body, 10 minutes each time, three times a week, for 6 weeks.

The researcher will explain to the participants about how to perform the stretching exercise, according to an instruction manual (hardcopy) for the exercise regimen.

A video is shown to the participants (the content same as hardcopy of education manual).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Patients with newly diagnosed primary lung cancer or esophageal cancer, from the first stage to the third stage.
2. At least 20 years of age.
3. Able to communicate in Mandarin Chinese or Taiwanese.
4. Literate and free from cognitive disabilities.
5. The attending physician agrees to participate in the study.
6. Those who can connect to the Internet with mobile devices such as computers, mobile phones, and tablets, or those whose family members can assist in the operation.
7. Those with Karnofsky Performance Scale (KPS) greater than or equal to 70 points.
8. Those who are hospitalized for lung cancer or esophageal cancer lesion resection.

Exclusion Criteria

1. Congestive heart failure.
2. Orthopedic diseases of the lower extremities that limit one's walking ability.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hui-Mei Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taipei University of Nursing and Health Sciences

Locations

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Taipei Veterans General Hospital

Taipei City, Taipei, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hui-Mei Chen, PhD

Role: CONTACT

886-2-28227101 ext. 3139

Mei-Fen Dai, MSN

Role: CONTACT

886-2-28757154

Facility Contacts

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Hui-Mei Chen, PhD

Role: primary

886-2-28227101 ext. 3139

References

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Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.

Reference Type BACKGROUND
PMID: 31626055 (View on PubMed)

Chen HM, Cheung DST, Lin YY, Wu YC, Liu CY, Lin KC, Lin YJ, Lin CC. Relationships of exercise timing with sleep, fatigue and rest-activity rhythms of lung cancer patients in Taiwan: An exploratory study. Eur J Cancer Care (Engl). 2020 Jul;29(4):e13233. doi: 10.1111/ecc.13233. Epub 2020 Feb 25.

Reference Type RESULT
PMID: 32100388 (View on PubMed)

Chen HM, Lee MC, Tian JY, Dai MF, Wu YC, Huang CS, Hsu PK, Duong LT. Relationships Among Physical Activity, Daylight Exposure, and Rest-Activity Circadian Rhythm in Patients With Esophageal and Gastric Cancer: An Exploratory Study. Cancer Nurs. 2024 Mar-Apr 01;47(2):112-120. doi: 10.1097/NCC.0000000000001188. Epub 2023 Jan 14.

Reference Type RESULT
PMID: 36728167 (View on PubMed)

Chen HM, Lin YY, Wu YC, Huang CS, Hsu PK, Chien LI, Lin YJ, Huang HL. Effects of Rehabilitation Program on Quality of Life, Sleep, Rest-Activity Rhythms, Anxiety, and Depression of Patients With Esophageal Cancer: A Pilot Randomized Controlled Trial. Cancer Nurs. 2022 Mar-Apr 01;45(2):E582-E593. doi: 10.1097/NCC.0000000000000953.

Reference Type RESULT
PMID: 33813524 (View on PubMed)

Chen HM, Tsai CM, Wu YC, Lin KC, Lin CC. Randomised controlled trial on the effectiveness of home-based walking exercise on anxiety, depression and cancer-related symptoms in patients with lung cancer. Br J Cancer. 2015 Feb 3;112(3):438-45. doi: 10.1038/bjc.2014.612. Epub 2014 Dec 9.

Reference Type RESULT
PMID: 25490525 (View on PubMed)

Chen HM, Tsai CM, Wu YC, Lin KC, Lin CC. Effect of walking on circadian rhythms and sleep quality of patients with lung cancer: a randomised controlled trial. Br J Cancer. 2016 Nov 22;115(11):1304-1312. doi: 10.1038/bjc.2016.356. Epub 2016 Nov 3.

Reference Type RESULT
PMID: 27811855 (View on PubMed)

Chen HM, Wu YC, Tsai CM, Tzeng JI, Lin CC. Relationships of Circadian Rhythms and Physical Activity With Objective Sleep Parameters in Lung Cancer Patients. Cancer Nurs. 2015 May-Jun;38(3):215-23. doi: 10.1097/NCC.0000000000000163.

Reference Type RESULT
PMID: 24945266 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/31626055/

Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable

Other Identifiers

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2023-04-003B

Identifier Type: -

Identifier Source: org_study_id

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